Nagoya Protocol & ABS Compliance Policy
Legal framework
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation is a supplementary agreement to the Convention on Biological Diversity (CBD). Madagascar is a Party to both the CBD and the Nagoya Protocol. IsoGentiX's access to Madagascar's genetic resources and associated traditional knowledge is subject to Madagascar's national ABS legislation and to the Nagoya Protocol's due diligence requirements as implemented in the UK and EU.
Prior Informed Consent
No biological material is accessed, collected, or removed from Madagascar without Prior Informed Consent (PIC) granted by the competent national authority — the Office National pour l'Environnement (ONE) or equivalent designated authority. PIC must be obtained before access occurs, not retrospectively. IsoGentiX will not proceed with any collection activity where PIC documentation is incomplete or where any condition of the PIC has not been satisfied.
Mutually Agreed Terms
All access to genetic resources is conducted under Mutually Agreed Terms (MAT) established with the relevant national authority and, where applicable, with local communities whose traditional knowledge is associated with the resources accessed. MAT documents are retained for the full duration of any downstream use of the resources and are made available to competent authorities on request.
Benefit-sharing obligations
IsoGentiX is committed to the fair and equitable sharing of benefits arising from utilisation of Madagascar's genetic resources. Benefit-sharing arrangements are specified in MAT and may include:
- Monetary payments — royalties, upfront fees, or milestone payments — to national authorities and designated community funds
- Capacity-building contributions — training, equipment, or technology transfer to Malagasy research institutions
- Non-monetary benefits — data sharing, co-authorship, and access to research outputs for national institutions
Benefit-sharing payments and in-kind contributions are made on the schedule specified in MAT. IsoGentiX does not defer or reduce benefit-sharing obligations on the basis of commercial pressure.
IRCC and due diligence
Where IsoGentiX's utilisation activities fall within the scope of the EU ABS Regulation or equivalent UK measures, IsoGentiX will obtain and retain the Internationally Recognised Certificate of Compliance (IRCC) issued via the ABS Clearing-House, or equivalent documentation. Due diligence declarations will be submitted to competent authorities as required.
Downstream licensing
Commercial licences granted by IsoGentiX for data derived from Madagascar genetic resources include contractual obligations on licensees to comply with Nagoya Protocol requirements in respect of any further utilisation. IsoGentiX will not knowingly license data to parties who intend to use it in breach of ABS obligations.
Record-keeping
IsoGentiX maintains records of all PIC documentation, MAT, IRCC registrations, and benefit-sharing payments for a minimum of twenty years from the date of access, or longer if required by applicable law or MAT conditions.